Manhattan Pharmaceuticals Expands Phase 2a Obesity Clinical Trial Sites to US
08 Novembre 2006 - 2:29PM
PR Newswire (US)
NEW YORK, Nov. 8 /PRNewswire-FirstCall/ -- Manhattan
Pharmaceuticals, Inc. (AMEX:MHA) today announced that it has
expanded the clinical trial sites for its ongoing Phase 2a study of
oral Oleoyl-estrone (OE) in obese adult subjects to the United
States. OE is the Company's orally administered product candidate
in development for the treatment of obesity. In addition to
recruiting patients in Switzerland, where the Phase 2a was
initiated in May 2006, the study will now also begin recruiting
patients at Jean Brown Research in Salt Lake City, UT and at
Pennington Biomedical Research Center in Baton Rouge, LA. Screening
of patients has already begun and dosing is expected to take place
in mid November 2006. This ongoing Phase 2a study is a randomized,
double-blind, placebo- controlled, parallel group study.
Approximately 100 obese adult subjects with a body mass index (BMI)
of 27-38.9 will be randomized into one of four treatment groups to
evaluate safety, preliminary efficacy, and pharmacokinetics of two
14-day dosing cycles of 5mg, 10mg, or 20mg of oral OE compared to
placebo given once daily during each 14-day dosing cycle. In
addition to safety and tolerability, this Phase 2a study is also
designed to further evaluate weight loss, maintenance of weight
loss, and other therapeutic outcomes. Manhattan Pharmaceuticals
also recently announced the initiation of a second Phase 2a
clinical trial of OE in morbidly obese male subjects (BMI 40- 55)
being conducted at St. Luke's-Roosevelt Hospital Center. OE is an
orally administered, synthetic form of oleoyl-estrone, a molecule
that exists naturally in the body. As shown in animal studies, it
is believed to work by a dual mechanism of action. Centrally, OE
appears to act at the hypothalamus, resetting the body's
ponderostat, the "food control center" in the brain that detects
and integrates signals that control both appetite and metabolic
behavior. Peripherally, OE also causes reduced storage of fat in
"white fat" tissue and allows skeletal muscle to use fat as an
alternate energy source. About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc., a development-stage pharmaceutical
company, acquires and develops proprietary prescription drugs for
large, underserved patient populations. In view of the worldwide
obesity epidemic, the company is developing OE, an orally
administered novel therapeutic for the treatment of obesity,
including morbid obesity. To meet the needs of other major,
underserved medical markets Manhattan Pharmaceuticals is also
developing PTH (1-34), a peptide believed to be a regulator of
epidermal cell growth, for the treatment of psoriasis, and Propofol
Lingual Spray, a convenient, proprietary lingual spray formulation
of propofol, the world's best-selling general anesthetic, as a
sedative-hypnotic for use during diagnostic and therapeutic
procedures. (http://www.manhattanpharma.com/) Note Regarding
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements involve
risks and uncertainties that could cause Manhattan Pharmaceutical's
actual results to differ materially from the anticipated results
and expectations expressed in these forward-looking statements.
These statements are often, but not always, made through the use of
words or phrases such as "anticipates," "expects," "plans,"
"believes," "intends," and similar words or phrases. These
statements are based on current expectations, forecasts and
assumptions that are subject to risks and uncertainties, which
could cause actual outcomes and results to differ materially from
these statements. Among other things, there can be no assurances
that any of Manhattan's development efforts relating to
Oleoyl-estrone and its other product candidates will be successful.
Other risks that may affect forward-looking information contained
in this press release include the possibility of being unable to
obtain regulatory approval of Manhattan's product candidates,
including Oleoyl- estrone, the risk that the results of clinical
trials may not support Manhattan's claims, Manhattan's reliance on
third-party researchers to develop its product candidates, and its
lack of experience in developing and commercializing pharmaceutical
products. Additional risks are described in the company's filings
with the Securities and Exchange Commission, including its Annual
Report on Form 10-KSB for the year ended December 31, 2005.
Manhattan assumes no obligation to update these statements, except
as required by law. Contact: Michelle Carroll Corporate
Communications Manhattan Pharmaceuticals, Inc. 212/582-3950 Thomas
Redington Redington, Inc. 203/222-7399 212/926-1733 DATASOURCE:
Manhattan Pharmaceuticals, Inc. CONTACT: Michelle Carroll,
Corporate Communications of Manhattan Pharmaceuticals, Inc.,
+1-212-582-3950 or Thomas Redington of Redington, Inc., for
Manhattan Pharmaceuticals, +1-203-222-7399 or +1-212-926-1733 Web
site: http://www.manhattanpharma.com/
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